BEUDAMED
    FDA Enforcement Class II Ongoing

    ADVIA Centaur Cortisol 50T (Material Number 10994924), ADVIA Centaur Cortisol 250T (Material Number 10994926), and ADVIA Centaur Cortisol REF 250T (Material Number 10994927). In vitro diagnostic use in the quantitative determination of cortisol in human serum, plasma (EDTA and lithium heparin), and urine.

    Recall: Z-1505-2023 · Reported May 10, 2023

    Enforcement

    Recall Number
    Z-1505-2023
    Event ID
    92059
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Siemens Healthcare Diagnostics, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 10, 2023
    Initiation Date
    March 16, 2023
    Classification Date
    May 3, 2023
    Address
    511 Benedict Ave, Tarrytown, NY, 10591-5005, United States

    Description

    ADVIA Centaur Cortisol 50T (Material Number 10994924), ADVIA Centaur Cortisol 250T (Material Number 10994926), and ADVIA Centaur Cortisol REF 250T (Material Number 10994927). In vitro diagnostic use in the quantitative determination of cortisol in human serum, plasma (EDTA and lithium heparin), and urine.

    Reason

    There is a negative bias with urine patient samples and urine cortisol Quality Control (QC) results intermittently out of range low.

    Code Info

    ADVIA Centaur Cortisol (50T) UDI-DI: 00630414602943; Kit Lot Numbers: 49741344 07241346 88318346 29109348 and higher; ADVIA Centaur Cortisol 250T UDI-DI: 00630414602950; Kit Lot Numbers: 49742344 88319346 29108348 and higher; ADVIA Centaur Cortisol (REF) 250T UDI-DI: 00630414598659; Kit Lot Numbers: 75474344 11352346 and higher

    Distribution

    Worldwide distribution - US Nationwide.

    Quantity

    18,961 kits